BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4181350 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07193
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE DEVICES DELIVER ANY STAPLES OR A CUT LINE BEFORE IT JAMMED? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? DURING WHICH STROKE DID THE EVENT OCCUR? WHAT COLOR CARTRIDGE WAS BEING USED? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? F/U RESPONSE FROM AFFILIATE: THE STAPLER SEIZED WITHOUT FIRING USING A WHITE CARTRIDGE. I THINK THE PROBLEM WAS THAT WE HAD EXTREME FLEXING AS I WAS STAPLING AROUND A CORNER. IT THEN WOULDN'T OPEN. ADDITIONAL INFORMATION REQUEST TO SALES REP: WERE BOTH DEVICES UNABLE TO BE OPENED? HOW WERE THE DEVICES REMOVED FROM TISSUE? DID THE JAWS OF THE DEVICE EVENTUALLY OPEN? F/U RESPONSE FROM SALES REP: I HAVE TRIED TO CONTACT THE SURGEON INVOLVED AND HE HAS NOT RESPONDED. IF I SHOULD GET A RESPONSE I WILL FORWARD IT ON.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE EC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60W CARTRIDGE LOADED ON THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEEN PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED AS INTENDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY PROCEDURE, TWO OF THE DEVICES JAMMED AND UPON USE OF THE THIRD DEVICE THE FIRING PROCESS WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660012 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1